Associate Director/Director, Biostatistics Job Category: General Requisition Number: ASSOC002028 Posted: April 30, 2025 Full-Time Headquarters: Vanda Pharmaceuticals HQ, Washington, DC 20037, USA Job Details Description Primary Responsibilities Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development, and Clinical Study Report (CSR) Participate study related activities and provide statistical consultation, input, and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician, and programming team in support of biostatistics operational activities Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected Provide statistical expertise by identifying potential issues, providing recommendations, and bringing in statistical experts external for relevant issues as needed Requirements Ph. D. in Biostatistics or statistics At least 4 years of pharmaceutical clinical trial experience In-depth knowledge of clinical trials methodology, regulatory requirements, statistics Comprehensive experience of SAS programming and R/S language Ability to effectively collaborate in a dynamic environment Excellent practical, organizational, interpersonal, oral, and written communication skills are a must Additional We are open to providing relocation for this position The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.